ChroniSense Polso Wrist Worn Respiration Rate Validation Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Respiratory Rate Accuracy of Polso Monitoring System
研究概览
简要总结
20 volunteer test subjects will be entered into an accuracy study that is designed to validate accuracy of the respiratory rate of the Polso Monitoring system
详细描述
20 volunteer test subjects will be entered into an accuracy study that is designed to validate accuracy of the respiratory rate of the Polso Monitoring system.
A range of stable respiratory rates will be elicited from each volunteer test subject. The rates will be approximately 5, 10, 15, 20, 25, 30, 35, 40 and 45 breaths per minute; with some natural variation from these exact numbers.
Each subject will be instrumented with an open system mask that allows for measurement of the end tidal carbon dioxide (EtCO2) respiratory rate and tidal volume. The EtCO2 monitor will be used as the Accuracy Reference Device (Reference) in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject must have the ability to understand and provide written informed consent
- •Subject is adult over 18 years of age
- •Subject must be willing and able to comply with study procedures and duration
- •Subject is a non-smoker
- •Male or female of any race
- •Wrist circumference with the range of 5.5-8 inches (13 to 21cm)
排除标准
- •Subject is considered as being morbidly obese (defined as BMI >39.5)
- •Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study. Tattoo in the optical path which would limit the ability to test sites needed for the study.
- •Subjects with known respiratory conditions such as:
- •uncontrolled / severe asthma,
- •pneumonia / bronchitis,
- •shortness of breath / respiratory distress,
- •respiratory or lung surgery,
- •emphysema, COPD, lung disease
- •Subjects with self-reported heart or cardiovascular conditions such as:
- •have had cardiovascular surgery
- •Chest pain (angina)
- •heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia
- •previous heart attack
- •blocked artery
- •unexplained shortness of breath
- •congestive heart failure (CHF)
- •history of stroke
- •transient ischemic attack
- •carotid artery disease
- •myocardial ischemia
- •myocardial infarction
- •cardiomyopathy
- •Self-reported health conditions as identified in the Health Assessment Form
- •diabetes,
- •uncontrolled thyroid disease,
- •kidney disease / chronic renal impairment,
- •history of seizures (except childhood febrile seizures),
- •epilepsy,
- •history of unexplained syncope,
- •recent history of frequent migraine headaches,
- •recent head injury within the last 2 months,
- •Cancer / chemotherapy
- •Other known health condition should be considered upon disclosure in health assessment form
结局指标
主要结局
Respiratory Rate Accuracy of Polso Monitoring System
时间窗: Through study completion, 1 month average
Respiratory Rate of test subject as compared to CO2 of End Tidal Carbon. Twenty second periods will be averaged to provide one respiratory rate value. Each stable respiratory rate plateau will result in four of these respiratory rate values which will be included in the ARMS calculation. The endpoint of interest is accuracy as measured by the Accuracy root-mean-square (Arms) difference between the device under test (DUT) and the reference respiratory rate system (Ref) for all stable respiratory periods. Acceptance criteria ARMS \<3
次要结局
未报告次要终点